What this study is
Lipoprotein(a), also known as Lp(a), is a protein that carries cholesterol and proteins in your blood. People with high Lp(a) have a higher risk for heart disease. The main purpose of the study is to investigate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the heart's vessels using an imaging technology known as Coronary Computed Tomography Angiography (CCTA) in adults who have high levels of Lp(a).
Participation will last about 120 weeks.
What's being tested
- Lepodisiran
Intervention · DRUG
- Placebo
Intervention · DRUG
Both interventions
Administered SC
Study details
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults With Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event
- Sponsor
- Eli Lilly and Company
- Conditions
- Atherosclerosis · Cardiovascular Diseases · Lipoprotein(a)
- Enrolling
- 252 people
- Starts
- 2026-06-01
- Est. completion
- 2029-12
- Design
- Double-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Have an Lp(a) ≥175 nmol/L
- Have established cardiovascular (CV) disease or are at risk for a first CV event
- Have angiographic evidence of coronary artery disease on screening CCTA
- If taking lipid-lowering medications, inclusive of statins or prescription strength niacin and PCSK9 inhibitors, these should be stable for 8 weeks
You can't join if
- Have had a major CV event less than 60 days before measurement of the Lp(a) level used for eligibility or uncontrolled high blood pressure at screening
- Have moderate to severe renal dysfunction
- Have severe heart failure
- Have a history of coronary artery bypass graft surgery (CABG)
- Have a planned coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft, or valvular intervention
- Have had a procedure to remove lipoproteins from the blood or received therapy specifically targeting Lp(a)
- Are unable to safely undergo CCTA due to medication intolerance, contrast allergies, or anatomical/technical factors
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (57)
57 openUCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, United States
- Contact858-246-2510
- Michael Wilkinson · Principal investigator
RecruitingValley Clinical Trials, Inc.
Northridge, California, United States
- Contact818-678-4900
- Mehrdad Ariani · Principal investigator
RecruitingLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
- Contact424-201-3000
- Ignacio Velazquez · Principal investigator
RecruitingJellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
- Contact954-963-7100
- Sam Lerman · Principal investigator
RecruitingJacksonville Center for Clinical Research
Jacksonville, Florida, United States
- Contact904-730-0101
- Erich Schramm · Principal investigator
RecruitingMerritt Island Medical Research, LLC
Merritt Island, Florida, United States
- David Kirk · Principal investigator
RecruitingInpatient Research Clinic
Miami Lakes, Florida, United States
- Contact786-502-4303
- Alexis Gutierrez · Principal investigator
RecruitingClinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States
- Contact407-740-8078
- Monica Aggarwal · Principal investigator
RecruitingHigh Desert Heart & Vascular
Meridian, Idaho, United States
- Contact208-398-4306
- David Hinchman · Principal investigator
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
- Contact617-726-1843
- Michael Honigberg · Principal investigator
Not yet recruitingProfound Research LLC
Farmington Hills, Michigan, United States
- Contact947-254-1920
- Herman-Simon Kado · Principal investigator
RecruitingVector Clinical Trials
Las Vegas, Nevada, United States
- Contact702-750-000
- Bharat Mocherla · Principal investigator
RecruitingHeart and Vascular Research at WellSpan Health
York, Pennsylvania, United States
- Contact717-851-2441
- Rhian Davies · Principal investigator
RecruitingIntermountain Medical Center
Murray, Utah, United States
- Contact801-507-4707
- Jeffrey Anderson · Principal investigator
RecruitingVirginia Heart
Falls Church, Virginia, United States
- Contact703-766-5920
- Tariq Haddad · Principal investigator
RecruitingCarilion Clinic
Roanoke, Virginia, United States
- Lana Wahid · Principal investigator
RecruitingEastside Research Associates
Redmond, Washington, United States
- Contact425-869-6828
- Christopher Price · Principal investigator
Recruiting
40 sites outside the US
Nightingale Research
Adelaide, Australia
- Andrew Hamilton · Principal investigator
RecruitingUniversity of the Sunshine Coast (UniSC) Clinical Trials - Birtinya
Birtinya, Australia
- Peter De Wet · Principal investigator
Recruiting- Recruiting
Advara HeartCare - Burwood
Burwood, Australia
- Vincent Khoury · Principal investigator
RecruitingAdvara HeartCare Joondalup
Joondalup, Australia
- Contact61894006111
- Peter Purnell · Principal investigator
RecruitingAdvara HeartCare Leabrook
Leabrook, Australia
- Jamie Morton · Principal investigator
Recruiting- Recruiting
USC Clinical Trials Brisbane (South Bank)
South Brisbane, Australia
- Carla Evangelista · Principal investigator
RecruitingClinitrials
West Perth, Australia
- Chris Judkins · Principal investigator
RecruitingFakultni Nemocnice u sv. Anny v Brne
Brno, Czechia
- Vladimir Kincl · Principal investigator
RecruitingEFERTUS healthcare s.r.o.
Brno, Czechia
- Contact420 606 417 244
- Hana Matejovska · Principal investigator
RecruitingTop Moravia Health
Brno, Czechia
- Contact00420 734 395 787
- Veronika Fendrychova · Principal investigator
RecruitingFakultni Nemocnice u sv. Anny v Brne
Brno, Czechia
- Robert Prosecky · Principal investigator
RecruitingÓbudai Egészségügyi Centrum
Budapest, Hungary
- Contact36 70 450 8040
- Viktor Vass · Principal investigator
Recruiting- Recruiting
Szabolcs Szatmár Bereg Vármegyei Oktatókórház
Nyíregyháza, Hungary
- Contact0036209530430
- Zsolt Zilahi · Principal investigator
RecruitingMedisch Spectrum Twente
Enschede, Netherlands
- Paolo Zocca · Principal investigator
RecruitingZiekenhuis St. Jansdal
Harderwijk, Netherlands
- Contact0341463745
- Marc van der Zee · Principal investigator
Not yet recruitingAlrijne Ziekenhuis, locatie Leiderdorp
Leiderdorp, Netherlands
- Contact0715828485
- Tjeerd Römer · Principal investigator
Not yet recruitingVieCuri Medisch Centrum, locatie Venlo
Venlo, Netherlands
- Contact0773205603
- Wouter Remkes · Principal investigator
Not yet recruitingCHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
- Contact34 628 544 729
- Jose Luis Diaz Diaz · Principal investigator
RecruitingParc de Salut Mar - Hospital del Mar
Barcelona, Spain
- Contact93 248 30 39
- Diego Pérez Zerpa · Principal investigator
RecruitingHospital Quiron Barcelona
Barcelona, Spain
- Contact932850000
- Fernando Cereto Castro · Principal investigator
RecruitingHospital Universitario Reina Sofia
Córdoba, Spain
- Contact34957010947
- Jose Lopez Miranda · Principal investigator
RecruitingHospital Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain
- Contact663873243
- Rosa María Sánchez Hernández · Principal investigator
RecruitingHospital Universitario Ramón y Cajal
Madrid, Spain
- Olivia Sanchez Sanchez · Principal investigator
RecruitingHospital Clinico San Carlos
Madrid, Spain
- Contact0034 913 30 30 00
- Manuel Mendez · Principal investigator
RecruitingHospital Universitario Virgen Macarena
Seville, Spain
- Contact34955034939
- Rafael Jesús Hidalgo Urbano · Principal investigator
RecruitingHospital Universitario Virgen Del Rocio
Seville, Spain
- Contact0034 955 01 20 00
- Luis Beltrán · Principal investigator
RecruitingHospital General Universitario de Valencia
Valencia, Spain
- Francesc Puchades · Principal investigator
RecruitingFutureMeds - Birmingham
Birmingham, United Kingdom
- Contact0121 592 2050
- Tehmina Ahmed · Principal investigator
RecruitingBristol Royal Infirmary
Bristol, United Kingdom
- Kofi Antwi · Principal investigator
RecruitingCheadle Community Hospital
Cheadle, United Kingdom
- Contact07452948414
- Mark Stone · Principal investigator
RecruitingRoyal Lancaster Infirmary
Lancaster, United Kingdom
- Mohamed Elnaggar · Principal investigator
RecruitingLincoln County Hospital
Lincoln, United Kingdom
- Vinod Venugopal · Principal investigator
RecruitingFuturemeds-Newcastle
Newcastle, United Kingdom
- William Aspinall · Principal investigator
RecruitingThe John Radcliffe Hospital
Oxford, United Kingdom
- Rafail Kotronias · Principal investigator
RecruitingSheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
- Contact+44 114 2266159
- Robert Storey · Principal investigator
Recruiting- Recruiting
FutureMeds Teesside - Middlefield Centre
Stockton-on-Tees, United Kingdom
- Contact01918205151
- Anneliese Flatt · Principal investigator
Recruiting
Study team
Sponsor
Eli Lilly and Company
Study ID 27554
Study director
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
CONTACT
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.